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Sars-cov-2 mrna (tozinameran-tris-sucrose) vaccine Pregnancy and Breastfeeding Warnings

Brand names: Comirnaty (Do Not Dilute), Pfizer-BioNTech COVID-19 Vaccine (Do Not Dilute)

Medically reviewed by Drugs.com. Last updated on May 2, 2023.

Sars-cov-2 mrna (tozinameran-tris-sucrose) vaccine Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: There are insufficient data available on use of this drug in pregnancy to inform of a drug related risk.

Comment: A pregnancy exposure registry is available.

Animal studies have failed to reveal evidence of fetal harm. Animal studies of a dose equivalent to a single human dose given on 4 occasions (twice prior to mating and twice during gestation) showed no evidence of developmental harm to the fetus. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Women vaccinated during pregnancy are encouraged to enroll in the registry by visiting https://mothertobaby.org/ongoing-study/covid19-vaccines/.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Sars-cov-2 mrna (tozinameran-tris-sucrose) vaccine Breastfeeding Warnings

Use is generally considered acceptable; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
---For preventive vaccines, the mother's underlying condition is susceptibility to disease prevented by the vaccine.

See references

References for pregnancy information

  1. US Food and Drug Administration (2020) Emergency Use Authorization. Emergency Use Authorization (EUA) information, and list of all current EUAs. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
  2. (2022) "Product Information. Pfizer-BioNTech COVID-19 Vaccine PF (SARS-CoV-2 mRNA (tozinameran) vaccine)." Pfizer Inc.

References for breastfeeding information

  1. National Library of Medicine (US) (2019) Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK501922/
  2. US Food and Drug Administration (2020) Emergency Use Authorization. Emergency Use Authorization (EUA) information, and list of all current EUAs. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
  3. (2022) "Product Information. Pfizer-BioNTech COVID-19 Vaccine PF (SARS-CoV-2 mRNA (tozinameran) vaccine)." Pfizer Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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